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Silver Hydrosol Informed Consent Agreement Rationale for the Use of Silver Hydrosol Medicinal use of silver spans over the past 3 thousand years, and it is currently routinely used topically to treat infections associated with burns and as eye drops in the newborn to prevent infectious-based blindness. With the emergence of antibiotic-resistant germs the traditional antimicrobial uses of silver are re-surfacing due to significant advances in nanotechnology. Present day silver-based drugs may have far-reaching benefits when administered intravenously, orally, topically and even rectally for specific kinds of infections. Safety and Benefits Currently the FDA does not recognize use of silver hydrosol. Many states do not recognize silver hydrosol within standards of medical care. Other states such as Texas are now recognizing proper use of silver hydrosol as allowable under standards of medical care. In view of this, no claim is being represented that this treatment will cure disease, and the treatment must be regarded as investigational. Silver hydrosol is currently not used by the majority of U.S. physicians, although this form of treatment is gaining wide interest among complementary and alternative leaning medical specialists. Colloidal silver products remain one of the major subjects of interest among web browsers looking for alternative approaches to difficult and/or complex infections. The older authoritative medical literature recognized a plethora of indications for the use of silver hydrosol. Silver, as silver ions, is scientifically established to be microcidal in nature. Up to the present time, infectious disease has not yet demonstrated germ resistance to oligodynamic silver when administered properly (i.e., in sufficient quantities that remain below EPA guidelines (lowest observed adverse event level or LOAEL). The Product The medical grade silver hydrosol product used in this treatment has been specifically selected due to its high concentration of silver ions, and its comprehensive superior quality. It is a stable, near neutral pH, pyrogen-free, sterile solution of dilute amounts of suspended silver, also known as colloidal silver. The recommended use of this silver product does not apply to silver preparations other than those specifically chosen by this physician. The extremely dilute yet powerful form of this product, due to its uniform particle size, makes it ideal to (a) minimize all known risks associated with silver administration, while at the same time (b) maximizing the penetration (adsorption) of the silver into infection sites within the body. Treatment Options Numerous conventional pharmaceutical treatments, other than the protocol being employed here, are available to the patient. You are free to choose which type of treatment protocol you would like to pursue at any time. You may also choose no treatment as an option. There is no harm from discontinuing silver hydrosol therapy at any time during your course of treatment, with the exception of interruption of your protocol which may forfeit future benefits. Treatment Scope This treatment protocol will involve acute and chronic infectious processes and patients who may be immune suppressed. 1 Purpose of This Treatment Our purpose is multi-fold: To improve the nutritional profile of patients under immune stress, To improve the patient’s diet; To bolster waste elimination, To identify any changes in the degree of the infectious processes, To gain insight and improve techniques in order to solve the consequences of infectious processes and to restore optimal immune function within as short a time frame as possible, To advance the known methods within medicine for the treatment of some of the most difficult and challenging infectious processes and immune disorders. Treatment Duration The treatment protocol is expected to last several days or weeks, but in certain cases the treatment protocol may span over a few months. Treatment Procedures The procedure will include: Optimal dietary measures which include adequate fiber and purified water consumption (1/2 oz per pound of body weight). Standard diagnostic testing, analysis and screening, including regular laboratory work-ups which may be ordered one or more times, such as: o immediately prior to beginning procedure; o at select intervals during course of treatment; and o at completion of the treatment. The procedure may include: Oral consumption of an all-natural, non-toxic nutritional supplements; Select detoxification procedures. Investigational Procedures of Treatment Protocol This protocol will involve the use of intravenous silver hydrosol administration. A simple intravenous push over 15 to 20 minutes, or a longer 3 hour intravenous drip may be administered by your physician as deemed medically necessary at appropriate times during the course of therapy. Foreseeable Risks or Discomforts of Treatment Protocol This treatment protocol involves administering quantities of silver that the Environmental Protection Agency (EPA) has determined presents no known health risks. The EPA (1998) has established a single adverse event which may result from exposure to silver quantities vastly exceeding this treatment protocol. This rare single adverse event involves a permanent discoloration of the skin called argyria. In 1990, the Agency for Toxic Substances and Disease Registry (ATSDR) likewise concluded there are no known risks or adverse events associated with silver except for argyria. Therefore, argyria is considered a medical benign condition which involves a permanent skin discoloration. The following patients may be at risk if they elect to undergo this protocol: 2 Patients with a known allergy to silver are not candidates for this protocol. If doubt arises as to whether a patient is indeed sensitive or allergic to silver, the physician may elect to test the patient with an injection just under the skin of 0.2cc of the silver hydrosol to observe for a red wheel reaction indicating the patient is indeed allergic to silver. Patients who may be unknowingly deficient in essential nutrients, such as selenium and vitamin E may rarely experience an uneventful, self-resolving and self-limiting swelling of the liver. This will pass in approximately 72 hours. Please notify your physician immediately if you notice any pressure or swelling around the upper right abdominal region. Patients with a history of liver disease should notify the physician of this medical history so the physician can take appropriate action to enhance liver function and liver detoxification procedures prior to and during the course of therapy. Patients who are pregnant and who may be experiencing pre-eclampsia or eclampsia should notify the physician of this condition prior to undergoing any treatment with silver hydrosol. Patients who have low adrenal function, or are taking medications which tend to induce low potassium levels, or in patients with known potassium deficiency should notify the physician immediately in order for the physician to institute procedures to restore normal potassium levels prior to treatment with silver hydrosol. Patients who have a history of sickle cell anemia must immediately notify the physician of this condition. Careful and thorough pre-loading with select nutrients such as Vitamin E are required if treatment is to be administered. Patients with other forms of anemia or low blood cell counts need to immediately notify the physician of this condition. Large doses of silver may bring about a temporary worsening of anemia, which is then typically associated with a rebounding toward normal blood levels after 72 hours post treatment. More infrequently, silver administration may induce anemia. For this reason, frequent monitoring with urine dip sticks may be ordered by your physician in order to detect an excess loss of red blood cells. Treatment Toxicity There is no known lethal dose established for silver. Jarisch-Herxheimer Events Some patients may unknowingly have slow waste removal capacity, and/or very heavy ‘loads” of infection. Silver hydrosol will efficiently break up infectious processes into debris. This infectious debris needs to exit the body, and can congest a liver which is sluggish or deficient in certain nutrients such as selenium and vitamin E. These patients may experience die-off symptoms which are nearly always self-resolving. Die-off events are known as Jarisch-Herxheimer Events (JHEs), which may include temporary chills and shakes (rigors), mild to moderate fever, nausea, muscle pains, joint pains, malaise, mental fatigue and/or headaches. 80% of patients receiving silver hydrosol in therapeutic doses may experience JHEs which are typically lessened or entirely prevented by consuming ½ gallon of organic Licorice and Green tea daily. 17% of this patient population may experience significant and intense JHEs. However, Licorice/Green tea typically checks such experiences. If frank JHEs arise, patients are strongly encouraged to increase their intake of Licorice/Green tea to 1 full gallon daily. It is permissible to use decaffeinated organic green tea if one is sensitive to caffeinated beverages. Most patients however, enjoy the slight increase in energy from the caffeinated form of organic green tea. Simply mix one (1) tea bag per cup of water for each type of tea respectively. For example, when making 16 cups at one 3 time of the tea, simply bring one gallon of water to a boil, and place 16 licorice and 16 green tea bags into the pot. Immediately turn off the burner. Let steep for 20 minutes and drink throughout the day. Lemon or soy milk creamer or organic half and half may be added as desired. Raw honey is the preferred sweetener, followed by Stevia, Mannitol or Xylitol. Taking pre-loading doses of select nutrients along with adequate Licorice/Green tea should easily prevent JHEs in the vast majority of patients. Nevertheless, if JHEs do arise despite these preventative steps, (a) slowing the rate of the intravenous drip, (b) reducing the amount of the intravenous drip, or (c) spacing out the frequency of intravenous drip may be ordered by your physician. If JHEs persist, the good news is that all symptoms typically disappear in 72 hours or less post treatment. Patient Confidentiality All patient documentation will be held in the strictest of confidence. However, if you do not object, raw data of your results may be taken for research purposes and medical publications. At no time will the patient’s name be used without the expressed written consent of the patient. If you have questions, comments, or concerns, please do not hesitate to contact your physician at: ______________________________________. Treatment Refusal You may elect to decline our recommendation for intravenous, oral, topical, nasal, or rectal use of silver hydrosol without incurring loss or any short of penalty. Treatment Costs Typical standard charges will apply. You will be charged for (a) the usual and customary office visit fee, (b) the required laboratory diagnostic testing, and (c) nutritional supplement costs just as any other patient would be. In cases of financial hardship, please contact the clinic administrator for more information. Patient Responsibility By signing below, I agree to abide by the following recommendations: 1. Prompt communication of any symptoms of concern to my physician; 2. Compliance with physician ordered medical monitoring to insure patient safety; 3. Compliance with all dietary, hydration and nutritional supplementation recommendations to prevent JHEs. I confirm that I have read and understood the above and agree to the provisions of this treatment: _____________________________________________ ___________________ Patient’s full name (printed) Clinic Patient’s ID _____________________________________________ Date: _______________, 2006 Patient’s Signature _____________________________________________ Physician’s (or authorized physician’s staff member) Signature 4 Date: _______________, 2006